Acute Pain Caused by Paclitaxel in Patients With Cancer

July 12, 2016 updated by: Alliance for Clinical Trials in Oncology

Paclitaxel-Associated Acute Pain Syndrome Natural History Study

RATIONALE: Gathering information over time from patients receiving paclitaxel for cancer may help doctors learn more about pain caused by paclitaxel and plan the best treatment.

PURPOSE: This clinical trial is studying acute pain caused by paclitaxel in patients with cancer.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Behavioral: pain questionnaires

Detailed Description

OBJECTIVES:

To describe the incidence and characteristics of and change in pain related to paclitaxel infusions over several courses in patients receiving paclitaxel weekly or every 2-4 weeks with or without neurotoxic chemotherapy.
To investigate the association between paclitaxel-induced acute pain syndrome symptoms and eventual chemotherapy-induced neuropathy.
To perform exome-sequencing analysis and identify genetic variants that predict paclitaxel- induced peripheral neuropathy.
To identify clinical phenotypes associated with paclitaxel toxicity (i.e., acute pain syndrome and neuropathy).
To explore whether there are any evident differences between results seen in the majority Caucasian population and the minority populations.

OUTLINE: This is a multicenter study. Patients are grouped according to paclitaxel dosing schedule (weekly vs every 2-4 weeks) and concurrent use of neurotoxic agent (yes vs no).

Blood samples are collected at baseline for correlative laboratory studies, including genetic biomarker and polymorphism studies.

Study Type

Observational

Enrollment (Actual)

306

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

United States
- Colorado
  - Aurora, Colorado, United States, 80012
    - Aurora Presbyterian Hospital
  - Boulder, Colorado, United States, 80301-9019
    - Boulder Community Hospital
  - Colorado Springs, Colorado, United States, 80933
    - Penrose Cancer Center at Penrose Hospital
  - Denver, Colorado, United States, 80210
    - Porter Adventist Hospital
  - Denver, Colorado, United States, 80220
    - Rose Medical Center
  - Denver, Colorado, United States, 80218
    - Presbyterian - St. Luke's Medical Center
  - Denver, Colorado, United States, 80204
    - St. Anthony Central Hospital
  - Denver, Colorado, United States, 80218
    - St. Joseph Hospital
  - Denver, Colorado, United States, 80224-2522
    - CCOP - Colorado Cancer Research Program
  - Englewood, Colorado, United States, 80110
    - Swedish Medical Center
  - Grand Junction, Colorado, United States, 81502
    - St. Mary's Regional Cancer Center at St. Mary's Hospital and Medical Center
  - Greeley, Colorado, United States, 80631
    - North Colorado Medical Center
  - Littleton, Colorado, United States, 80122
    - Littleton Adventist Hospital
  - Lone Tree, Colorado, United States, 80124
    - Sky Ridge Medical Center
  - Longmont, Colorado, United States, 80501
    - Hope Cancer Care Center at Longmont United Hospital
  - Loveland, Colorado, United States, 80539
    - McKee Medical Center
  - Parker, Colorado, United States, 80138
    - Parker Adventist Hospital
  - Pueblo, Colorado, United States, 81004
    - St. Mary - Corwin Regional Medical Center
  - Thornton, Colorado, United States, 80229
    - North Suburban Medical Center
  - Wheat Ridge, Colorado, United States, 80033
    - Exempla Lutheran Medical Center
- Connecticut
  - Hartford, Connecticut, United States, 06105
    - Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center
- Hawaii
  - Aiea, Hawaii, United States, 96701
    - Kapiolani Medical Center at Pali Momi
  - Honolulu, Hawaii, United States, 96813
    - Cancer Research Center of Hawaii
  - Honolulu, Hawaii, United States, 96826
    - Kapiolani Medical Center for Women and Children
  - Honolulu, Hawaii, United States, 96813
    - OnCare Hawaii, Incorporated - Lusitana
  - Honolulu, Hawaii, United States, 96813
    - Queen's Cancer Institute at Queen's Medical Center
  - Honolulu, Hawaii, United States, 96813
    - Straub Clinic and Hospital, Incorporated
  - Honolulu, Hawaii, United States, 96817
    - Hawaii Medical Center - East
  - Honolulu, Hawaii, United States, 96817
    - OnCare Hawaii, Incorporated - Kuakini
  - Honolulu, Hawaii, United States, 96859
    - Tripler Army Medical Center
  - Lihue, Hawaii, United States, 96766
    - Kauai Medical Clinic
  - Wailuku, Hawaii, United States, 96793
    - Maui Memorial Medical Center
  - Wailuku, Hawaii, United States, 96793
    - Pacific Cancer Institute - Maui
- Idaho
  - Boise, Idaho, United States, 83706
    - Saint Alphonsus Cancer Care Center at Saint Alphonsus Regional Medical Center
- Illinois
  - Bloomington, Illinois, United States, 61701
    - St. Joseph Medical Center
  - Bloomington%, Illinois, United States, 61701
    - Illinois CancerCare - Bloomington
  - Canton, Illinois, United States, 61520
    - Illinois CancerCare - Canton
  - Canton, Illinois, United States, 61520
    - Graham Hospital
  - Carthage, Illinois, United States, 62321
    - Memorial Hospital
  - Carthage, Illinois, United States, 62321
    - Illinois CancerCare - Carthage
  - Eureka, Illinois, United States, 61530
    - Illinois CancerCare - Eureka
  - Eureka, Illinois, United States, 61530
    - Eureka Community Hospital
  - Galesburg, Illinois, United States, 61401
    - Illinois CancerCare - Galesburg
  - Galesburg, Illinois, United States, 61401
    - Galesburg Clinic, PC
  - Havana, Illinois, United States, 62644
    - Mason District Hospital
  - Havana, Illinois, United States, 62644
    - Illinois CancerCare - Havana
  - Kewanee, Illinois, United States, 61443
    - Illinois CancerCare - Kewanee Clinic
  - Macomb, Illinois, United States, 61455
    - Illinois CancerCare - Macomb
  - Macomb, Illinois, United States, 61455
    - Mcdonough District Hospital
  - Moline, Illinois, United States, 61265
  - Moline, Illinois, United States, 61265
    - Trinity Cancer Center at Trinity Medical Center - 7th Street Campus
  - Monmouth, Illinois, United States, 61462
    - Illinois CancerCare - Monmouth
  - Monmouth, Illinois, United States, 61462
    - OSF Holy Family Medical Center
  - Normal, Illinois, United States, 61761
    - Bromenn Regional Medical Center
  - Normal, Illinois, United States, 61761
    - Community Cancer Center
  - Normal, Illinois, United States, 61761
    - Illinois CancerCare - Community Cancer Center
  - Ottawa, Illinois, United States, 61350
    - Community Hospital of Ottawa
  - Ottawa, Illinois, United States, 61350
    - Oncology Hematology Associates of Central Illinois, PC - Ottawa
  - Pekin, Illinois, United States, 61554
    - Cancer Treatment Center at Pekin Hospital
  - Pekin, Illinois, United States, 61603
    - Illinois CancerCare - Pekin
  - Peoria, Illinois, United States, 61636
    - Methodist Medical Center of Illinois
  - Peoria, Illinois, United States, 61614
    - Proctor Hospital
  - Peoria, Illinois, United States, 61637
    - OSF St. Francis Medical Center
  - Peoria, Illinois, United States, 61615
    - CCOP - Illinois Oncology Research Association
  - Peoria, Illinois, United States, 61615
    - Oncology Hematology Associates of Central Illinois, PC - Peoria
  - Peru, Illinois, United States, 61354
    - Illinois CancerCare - Peru
  - Peru, Illinois, United States, 61354
    - Illinois Valley Community Hospital
  - Princeton, Illinois, United States, 61356
    - Perry Memorial Hospital
  - Princeton, Illinois, United States, 61356
    - Illinois CancerCare - Princeton
  - Spring Valley, Illinois, United States, 61362
    - Illinois CancerCare - Spring Valley
- Indiana
  - Elkhart, Indiana, United States, 46515
    - Elkhart General Hospital
  - Elkhart, Indiana, United States, 46514
    - Michiana Hematology-Oncology, PC - Elkhart
  - Kokomo, Indiana, United States, 46904
    - Howard Community Hospital
  - La Porte, Indiana, United States, 46350
    - Center for Cancer Therapy at LaPorte Hospital and Health Services
  - Mishawaka, Indiana, United States, 46545-1470
    - Michiana Hematology-Oncology, PC - South Bend
  - Mishawaka, Indiana, United States, 46545-1470
    - Saint Joseph Regional Medical Center
  - Plymouth, Indiana, United States, 46563
    - Michiana Hematology Oncology PC - Plymouth
  - South Bend, Indiana, United States, 46601
    - Memorial Hospital of South Bend
  - South Bend, Indiana, United States, 46601
    - CCOP - Northern Indiana CR Consortium
  - Westville, Indiana, United States, 46391
    - Michiana Hematology Oncology PC - La Porte
- Iowa
  - Ames, Iowa, United States, 50010
    - McFarland Clinic, PC
  - Bettendorf, Iowa, United States, 52722
  - Cedar Rapids, Iowa, United States, 52403
    - Cedar Rapids Oncology Associates
  - Cedar Rapids, Iowa, United States, 52403
    - Mercy Regional Cancer Center at Mercy Medical Center
  - Clive, Iowa, United States, 50325
    - Medical Oncology and Hematology Associates - West Des Moines
  - Des Moines, Iowa, United States, 50309
    - CCOP - Iowa Oncology Research Association
  - Des Moines, Iowa, United States, 50309
    - John Stoddard Cancer Center at Iowa Methodist Medical Center
  - Des Moines, Iowa, United States, 50309
    - Medical Oncology and Hematology Associates at John Stoddard Cancer Center
  - Des Moines, Iowa, United States, 50314
    - Medical Oncology and Hematology Associates at Mercy Cancer Center
  - Des Moines, Iowa, United States, 50314
    - Mercy Cancer Center at Mercy Medical Center - Des Moines
  - Des Moines, Iowa, United States, 50316
    - John Stoddard Cancer Center at Iowa Lutheran Hospital
  - Mason City, Iowa, United States, 50401
    - Mercy Cancer Center at Mercy Medical Center - North Iowa
  - Ottumwa, Iowa, United States, 52501
    - McCreery Cancer Center at Ottumwa Regional
  - Sioux City, Iowa, United States, 51101
    - Siouxland Hematology-Oncology Associates, LLP
  - Sioux City, Iowa, United States, 51102
    - Mercy Medical Center - Sioux City
  - Sioux City, Iowa, United States, 51104
    - St. Luke's Regional Medical Center
- Kansas
  - Chanute, Kansas, United States, 66720
    - Cancer Center of Kansas, PA - Chanute
  - Dodge City, Kansas, United States, 67801
    - Cancer Center of Kansas, PA - Dodge City
  - El Dorado, Kansas, United States, 67042
    - Cancer Center of Kansas, PA - El Dorado
  - Fort Scott, Kansas, United States, 66701
    - Cancer Center of Kansas - Fort Scott
  - Independence, Kansas, United States, 67301
    - Cancer Center of Kansas-Independence
  - Kingman, Kansas, United States, 67068
    - Cancer Center of Kansas, PA - Kingman
  - Lawrence, Kansas, United States, 66044
    - Lawrence Memorial Hospital
  - Liberal, Kansas, United States, 67901
    - Cancer Center of Kansas, PA - Liberal
  - McPherson, Kansas, United States, 67460
    - Cancer Center of Kansas, PA - McPherson
  - Newton, Kansas, United States, 67114
    - Cancer Center of Kansas, PA - Newton
  - Parsons, Kansas, United States, 67357
    - Cancer Center of Kansas, PA - Parsons
  - Pratt, Kansas, United States, 67124
    - Cancer Center of Kansas, PA - Pratt
  - Salina, Kansas, United States, 67401
    - Cancer Center of Kansas, PA - Salina
  - Wellington, Kansas, United States, 67152
    - Cancer Center of Kansas, PA - Wellington
  - Wichita, Kansas, United States, 67208
    - Cancer Center of Kansas, PA - Medical Arts Tower
  - Wichita, Kansas, United States, 67214
    - Cancer Center of Kansas, PA - Wichita
  - Wichita, Kansas, United States, 67214
    - CCOP - Wichita
  - Wichita, Kansas, United States, 67214
    - Via Christi Cancer Center at Via Christi Regional Medical Center
  - Wichita, Kansas, United States, 67208
    - Associates in Womens Health, PA - North Review
  - Winfield, Kansas, United States, 67156
    - Cancer Center of Kansas, PA - Winfield
- Louisiana
  - Baton Rouge, Louisiana, United States, 70809
    - Ochsner Health Center - Bluebonnet
  - New Orleans, Louisiana, United States, 70121
    - CCOP - Ochsner
  - New Orleans, Louisiana, United States, 70121
    - Ochsner Cancer Institute at Ochsner Clinic Foundation
- Michigan
  - Adrian, Michigan, United States, 49221
    - Hickman Cancer Center at Bixby Medical Center
  - Ann Arbor, Michigan, United States, 48106-0995
    - Saint Joseph Mercy Cancer Center
  - Ann Arbor, Michigan, United States, 48106
    - CCOP - Michigan Cancer Research Consortium
  - Battle Creek, Michigan, United States, 49017
    - Battle Creek Health System Cancer Care Center
  - Big Rapids, Michigan, United States, 49307
    - Mecosta County Medical Center
  - Dearborn, Michigan, United States, 48123-2500
    - Oakwood Cancer Center at Oakwood Hospital and Medical Center
  - Escanaba, Michigan, United States, 49431
    - Green Bay Oncology, Limited - Escanaba
  - Flint, Michigan, United States, 48503
    - Hurley Medical Center
  - Flint, Michigan, United States, 48503
    - Genesys Hurley Cancer Institute
  - Grand Rapids, Michigan, United States, 49503
    - Butterworth Hospital at Spectrum Health
  - Grand Rapids, Michigan, United States, 49503
    - CCOP - Grand Rapids
  - Grand Rapids, Michigan, United States, 49503
    - Lacks Cancer Center at Saint Mary's Health Care
  - Grosse Pointe Woods, Michigan, United States, 48236
    - Van Elslander Cancer Center at St. John Hospital and Medical Center
  - Iron Mountain, Michigan, United States, 49801
    - Dickinson County Healthcare System
  - Jackson, Michigan, United States, 49201
    - Foote Memorial Hospital
  - Lansing, Michigan, United States, 48912-1811
    - Sparrow Regional Cancer Center
  - Livonia, Michigan, United States, 48154
    - St. Mary Mercy Hospital
  - Monroe, Michigan, United States, 48162
    - Community Cancer Center of Monroe
  - Monroe, Michigan, United States, 48162
    - Mercy Memorial Hospital - Monroe
  - Muskegon, Michigan, United States, 49443
    - Mercy General Health Partners
  - Pontiac, Michigan, United States, 48341-2985
    - St. Joseph Mercy Oakland
  - Port Huron, Michigan, United States, 48060
    - Mercy Regional Cancer Center at Mercy Hospital
  - Saginaw, Michigan, United States, 48601
    - Seton Cancer Institute at Saint Mary's - Saginaw
  - Saint Joseph, Michigan, United States, 49085
    - Lakeside Cancer Specialists, PLLC
  - St. Joseph, Michigan, United States, 49085
    - Lakeland Regional Cancer Care Center - St. Joseph
  - Traverse City, Michigan, United States, 49684
    - Munson Medical Center
  - Warren, Michigan, United States, 48093
    - St. John Macomb Hospital
- Minnesota
  - Alexandria, Minnesota, United States, 56308
  - Bemidji, Minnesota, United States, 56601
    - MeritCare Bemidji
  - Burnsville, Minnesota, United States, 55337
    - Fairview Ridges Hospital
  - Coon Rapids, Minnesota, United States, 55433
    - Mercy and Unity Cancer Center at Mercy Hospital
  - Duluth, Minnesota, United States, 55805
    - CCOP - Duluth
  - Duluth, Minnesota, United States, 55805-1983
    - Duluth Clinic Cancer Center - Duluth
  - Duluth, Minnesota, United States, 55805
    - Miller - Dwan Medical Center
  - Edina, Minnesota, United States, 55435
    - Fairview Southdale Hospital
  - Fridley, Minnesota, United States, 55432
    - Mercy and Unity Cancer Center at Unity Hospital
  - Hutchinson, Minnesota, United States, 55350
    - Hutchinson Area Health Care
  - Mankato, Minnesota, United States, 56002
    - Immanuel St. Joseph's
  - Maplewood, Minnesota, United States, 55109
    - HealthEast Cancer Care at St. John's Hospital
  - Maplewood, Minnesota, United States, 55109
    - Minnesota Oncology - Maplewood
  - Minneapolis, Minnesota, United States, 55407
    - Virginia Piper Cancer Institute at Abbott - Northwestern Hospital
  - Minneapolis, Minnesota, United States, 55415
    - Hennepin County Medical Center - Minneapolis
  - New Ulm, Minnesota, United States, 56073
    - New Ulm Medical Center
  - Robbinsdale, Minnesota, United States, 55422-2900
    - Humphrey Cancer Center at North Memorial Outpatient Center
  - Rochester, Minnesota, United States, 55905
    - Mayo Clinic Cancer Center
  - Saint Cloud, Minnesota, United States, 56303
    - CentraCare Clinic - River Campus
  - Saint Cloud, Minnesota, United States, 56303
    - Coborn Cancer Center
  - Saint Louis Park, Minnesota, United States, 55416
    - CCOP - Metro-Minnesota
  - Saint Louis Park, Minnesota, United States, 55416
    - Park Nicollet Cancer Center
  - Saint Paul, Minnesota, United States, 55102
    - United Hospital
  - Shakopee, Minnesota, United States, 55379
    - St. Francis Cancer Center at St. Francis Medical Center
  - St. Paul, Minnesota, United States, 55101
    - Regions Hospital Cancer Care Center
  - Stillwater, Minnesota, United States, 55082
    - Lakeview Hospital
  - Waconia, Minnesota, United States, 55387
    - Ridgeview Medical Center
  - Willmar, Minnesota, United States, 56201
    - Willmar Cancer Center at Rice Memorial Hospital
  - Woodbury, Minnesota, United States, 55125
    - Minnesota Oncology - Woodbury
- Missouri
  - Cape Girardeau, Missouri, United States, 63703
    - Southeast Cancer Center
  - Jefferson City, Missouri, United States, 65109
    - Goldschmidt Cancer Center
  - Saint Louis, Missouri, United States, 63131
    - Missouri Baptist Cancer Center
  - Saint Louis, Missouri, United States, 63141
    - Comprehensive Cancer Care, PC
- Montana
  - Billings, Montana, United States, 59101
    - CCOP - Montana Cancer Consortium
  - Billings, Montana, United States, 59101
    - St. Vincent Healthcare Cancer Care Services
  - Billings, Montana, United States, 59107-7000
    - Billings Clinic - Downtown
  - Billings, Montana, United States, 59102
    - Hematology-Oncology Centers of the Northern Rockies - Billings
  - Bozeman, Montana, United States, 59715
    - Bozeman Deaconess Cancer Center
  - Butte, Montana, United States, 59701
    - St. James Healthcare Cancer Care
  - Great Falls, Montana, United States, 59405
    - Great Falls Clinic - Main Facility
  - Great Falls, Montana, United States, 59405
    - Sletten Cancer Institute at Benefis Healthcare
  - Havre, Montana, United States, 59501
    - Northern Montana Hospital
  - Helena, Montana, United States, 59601
    - St. Peter's Hospital
  - Kalispell, Montana, United States, 59901
    - Kalispell Regional Medical Center
  - Kalispell, Montana, United States, 59901
    - Glacier Oncology, PLLC
  - Kalispell, Montana, United States, 59901
    - Kalispell Medical Oncology at KRMC
  - Missoula, Montana, United States, 59807-7877
    - Montana Cancer Specialists at Montana Cancer Center
  - Missoula, Montana, United States, 59807
    - Montana Cancer Center at St. Patrick Hospital and Health Sciences Center
- Nebraska
  - Lincoln, Nebraska, United States, 68510
    - Cancer Resource Center - Lincoln
  - Omaha, Nebraska, United States, 68106
    - CCOP - Missouri Valley Cancer Consortium
  - Omaha, Nebraska, United States, 68122
    - Immanuel Medical Center
  - Omaha, Nebraska, United States, 68124
    - Alegant Health Cancer Center at Bergan Mercy Medical Center
  - Omaha, Nebraska, United States, 68131-2197
    - Creighton University Medical Center
  - Omaha, Nebraska, United States, 68130
    - Lakeside Hospital
- North Dakota
  - Bismarck, North Dakota, United States, 58501
    - Bismarck Cancer Center
  - Bismarck, North Dakota, United States, 58501
    - Medcenter One Hospital Cancer Care Center
  - Bismarck, North Dakota, United States, 58501
    - Mid Dakota Clinic, PC
  - Bismarck, North Dakota, United States, 58502
    - St. Alexius Medical Center Cancer Center
  - Fargo, North Dakota, United States, 58122
    - CCOP - MeritCare Hospital
  - Fargo, North Dakota, United States, 58102
    - MeritCare Broadway
  - Fargo, North Dakota, United States, 58122
    - Roger Maris Cancer Center at MeritCare Hospital
- Ohio
  - Bowling Green, Ohio, United States, 43402
    - Wood County Oncology Center
  - Chillicothe, Ohio, United States, 45601
    - Adena Regional Medical Center
  - Columbus, Ohio, United States, 43214-3998
    - Riverside Methodist Hospital Cancer Care
  - Columbus, Ohio, United States, 43222
    - Mount Carmel Health - West Hospital
  - Columbus, Ohio, United States, 43215
    - CCOP - Columbus
  - Columbus, Ohio, United States, 43215
    - Grant Medical Center Cancer Care
  - Columbus, Ohio, United States, 43228
    - Doctors Hospital at Ohio Health
  - Delaware, Ohio, United States, 43015
    - Grady Memorial Hospital
  - Elyria, Ohio, United States, 44035
    - Community Cancer Center
  - Elyria, Ohio, United States, 44035
    - Hematology Oncology Center
  - Lancaster, Ohio, United States, 43130
    - Fairfield Medical Center
  - Lima, Ohio, United States, 45804
    - Lima Memorial Hospital
  - Marietta, Ohio, United States, 45750
    - Strecker Cancer Center at Marietta Memorial Hospital
  - Maumee, Ohio, United States, 43537-1839
    - Northwest Ohio Oncology Center
  - Mount Vernon, Ohio, United States, 43050
    - Knox Community Hospital
  - Newark, Ohio, United States, 43055
    - Licking Memorial Cancer Care Program at Licking Memorial Hospital
  - Norwalk, Ohio, United States, 44857
    - Fisher-Titus Medical Center
  - Oregon, Ohio, United States, 43616
    - St. Charles Mercy Hospital
  - Oregon, Ohio, United States, 43616
    - Toledo Clinic - Oregon
  - Portsmouth, Ohio, United States, 45662
    - Southern Ohio Medical Center Cancer Center
  - Sandusky, Ohio, United States, 44870
    - North Coast Cancer Care, Incorporated
  - Springfield, Ohio, United States, 45505
    - Community Hospital of Springfield and Clark County
  - Sylvania, Ohio, United States, 43560
    - Flower Hospital Cancer Center
  - Tiffin, Ohio, United States, 44883
    - Mercy Hospital of Tiffin
  - Toledo, Ohio, United States, 43608
    - St. Vincent Mercy Medical Center
  - Toledo, Ohio, United States, 43606
    - Toledo Hospital
  - Toledo, Ohio, United States, 43614
    - Medical University of Ohio Cancer Center
  - Toledo, Ohio, United States, 43617
    - CCOP - Toledo Community Hospital
  - Toledo, Ohio, United States, 43623
    - Toledo Clinic, Incorporated - Main Clinic
  - Toledo, Ohio, United States, 43623
    - St. Anne Mercy Hospital
  - Wauseon, Ohio, United States, 43567
    - Fulton County Health Center
  - Westerville, Ohio, United States, 43081
    - Mount Carmel St. Ann's Cancer Center
  - Zanesville, Ohio, United States, 43701
    - Genesis - Good Samaritan Hospital
- Oklahoma
  - Tulsa, Oklahoma, United States, 74136
    - Natalie Warren Bryant Cancer Center at St. Francis Hospital
- Oregon
  - Clackamas, Oregon, United States, 97015
    - Clackamas Radiation Oncology Center
  - Milwaukie, Oregon, United States, 97222
    - Providence Milwaukie Hospital
  - Newberg, Oregon, United States, 97132
    - Providence Newberg Medical Center
  - Oregon City, Oregon, United States, 97045
    - Willamette Falls Hospital
  - Portland, Oregon, United States, 97213-2967
    - Providence Cancer Center at Providence Portland Medical Center
  - Portland, Oregon, United States, 97225
    - CCOP - Columbia River Oncology Program
  - Portland, Oregon, United States, 97225
    - Providence St. Vincent Medical Center
- Pennsylvania
  - Danville, Pennsylvania, United States, 17822-0001
    - Geisinger Cancer Institute at Geisinger Health
  - Hazleton, Pennsylvania, United States, 18201
    - Geisinger Hazleton Cancer Center
  - State College, Pennsylvania, United States, 16801
    - Geisinger Medical Group - Scenery Park
  - Wilkes-Barre, Pennsylvania, United States, 18711
    - Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center
- South Dakota
  - Rapid City, South Dakota, United States, 57701
    - Rapid City Regional Hospital
  - Sioux Falls, South Dakota, United States, 57117-5039
    - Sanford Cancer Center at Sanford USD Medical Center
- Virginia
  - Fredericksburg, Virginia, United States, 22401
    - Fredericksburg Oncology, Incorporated
  - Richmond, Virginia, United States, 23298-0037
    - Virginia Commonwealth University Massey Cancer Center
- Washington
  - Seattle, Washington, United States, 98101
    - Virginia Mason Medical Center
  - Seattle, Washington, United States, 98101
    - CCOP - Virginia Mason Research Center
  - Vancouver, Washington, United States, 98664
    - Southwest Washington Medical Center Cancer Center
- Wisconsin
  - Chippewa Falls, Wisconsin, United States, 54729
    - Marshfield Clinic - Chippewa Center
  - Eau Claire, Wisconsin, United States, 54701
    - Marshfield Clinic Cancer Care at Regional Cancer Center
  - Fond du Lac, Wisconsin, United States, 54935
    - Central Wisconsin Cancer Program at Agnesian HealthCare
  - Green Bay, Wisconsin, United States, 54307-3508
    - St. Vincent Hospital Regional Cancer Center
  - Green Bay, Wisconsin, United States, 54301-3526
    - Green Bay Oncology, Limited at St. Vincent Hospital Regional Cancer Center
  - Green Bay, Wisconsin, United States, 54303
    - Green Bay Oncology, Limited at St. Mary's Hospital
  - Green Bay, Wisconsin, United States, 54303
    - St. Mary's Hospital Medical Center - Green Bay
  - Manitowoc, Wisconsin, United States, 54221-1450
    - Holy Family Memorial Medical Center Cancer Care Center
  - Marinette, Wisconsin, United States, 54143
    - Bay Area Cancer Care Center at Bay Area Medical Center
  - Marshfield, Wisconsin, United States, 54449
    - Marshfield Clinic - Marshfield Center
  - Minocqua, Wisconsin, United States, 54548
    - Marshfield Clinic - Lakeland Center
  - Oconto Falls, Wisconsin, United States, 54154
    - Green Bay Oncology, Limited - Oconto Falls
  - Rhinelander, Wisconsin, United States, 54501
    - Ministry Medical Group at Saint Mary's Hospital
  - Rice Lake, Wisconsin, United States, 54868
    - Marshfield Clinic - Indianhead Center
  - Sheboygan, Wisconsin, United States, 53081
    - St. Nicholas Hospital
  - Stevens Point, Wisconsin, United States, 54481
    - Marshfield Clinic at Saint Michael's Hospital
  - Sturgeon Bay, Wisconsin, United States, 54235
    - Green Bay Oncology, Limited - Sturgeon Bay
  - Weston, Wisconsin, United States, 54476
    - Marshfield Clinic - Weston Center
  - Wisconsin Rapids, Wisconsin, United States, 54494
    - Marshfield Clinic - Wisconsin Rapids Center
- Wyoming
  - Sheridan, Wyoming, United States, 82801
    - Welch Cancer Center at Sheridan Memorial Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients diagnosed with cancer who are planning to receive paclitaxel IV at least 175 mg/m^2 at 2-4 week intervals (course duration of 2, 3, or 4 weeks, respectively) or 70-90 mg/m^2 weekly (3 out of 4 weeks allowed).

Description

DISEASE CHARACTERISTICS:

Diagnosis of cancer
Planning to receive paclitaxel IV (excluding paclitaxel albumin-stabilized nanoparticle formulation [nab-paclitaxel]) according to one of the following dosing schedules:
- At least 175 mg/m^2 at 2-4 week intervals (course duration of 2, 3, or 4 weeks, respectively)
- 70-90 mg/m^2 weekly (3 out of 4 weeks allowed)

PATIENT CHARACTERISTICS:

ECOG performance status 0-1
Life expectancy > 6 months
Able to complete questionnaires (alone or with assistance)
Willing to provide required biological specimens
No prior or concurrent peripheral neuropathy (from diabetes or other causes)
No prior or concurrent fibromyalgia

PRIOR CONCURRENT THERAPY:

See Disease Characteristics
No prior paclitaxel or neurotoxic chemotherapy drugs, including other taxanes, platinum agents, vinca alkaloids, or epothilones
No concurrent neutrophil colony-stimulating factor therapy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Number of groups / cohorts

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Group I Patients complete pain questionnaires at baseline, 2-8 days after each weekly paclitaxel treatment given in combination with a neurotoxic agent, and then monthly for 1 year. Information about the type, location, and duration of pain and neuropathy as well as types of interventions used to manage the pain symptoms and the patients' pain responses is collected.	Behavioral: pain questionnaires
Group II Patients complete pain questionnaires at baseline, 2-8 days after each weekly paclitaxel treatment not given in combination with a neurotoxic agent, and then monthly for 1 year. Information about the type, location, and duration of pain and neuropathy as well as types of interventions used to manage the pain symptoms and the patients' pain responses is collected.	Behavioral: pain questionnaires
Group III Patients complete pain questionnaires at baseline, 2-8 days after each 2-4 week paclitaxel treatment given in combination with a neurotoxic agent, and then monthly for 1 year. Information about the type, location, and duration of pain and neuropathy as well as types of interventions used to manage the pain symptoms and the patients' pain responses is collected.	Behavioral: pain questionnaires
Group IV Patients complete pain questionnaires at baseline, 2-8 days after each 2-4 week paclitaxel treatment not given in combination with a neurotoxic agent, and then monthly for 1 year. Information about the type, location, and duration of pain and neuropathy as well as types of interventions used to manage the pain symptoms and the patients' pain responses is collected.	Behavioral: pain questionnaires

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Maximum of the worst pain scores from the initiation of paclitaxel therapy (day 1) until day 7 (first week of therapy) Time Frame: Up to day 7	Up to day 7

Secondary Outcome Measures

Outcome Measure	Time Frame
Maximum of the average pain score Time Frame: Up to 12 months	Up to 12 months
Area under the curve of worst, average, and least pain Time Frame: Up to 12 months	Up to 12 months
Worst pain reported for the overall week Time Frame: Up to 12 months	Up to 12 months
Rate of non-prescription pain medication use Time Frame: Up to 12 months	Up to 12 months
Rate of opioid use Time Frame: Up to 12 months	Up to 12 months
Rate of other pain therapy use Time Frame: Up to 12 months	Up to 12 months
Correlation of the worst pain score for the first dose of therapy with subsequent neuropathy scores Time Frame: Up to 12 months	Up to 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alliance for Clinical Trials in Oncology

Collaborators

National Cancer Institute (NCI)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2009

Primary Completion (Actual)

April 1, 2011

Study Completion (Actual)

May 1, 2013

Study Registration Dates

First Submitted

March 10, 2009

First Submitted That Met QC Criteria

March 10, 2009

First Posted (Estimate)

March 11, 2009

Study Record Updates

Last Update Posted (Estimate)

July 14, 2016

Last Update Submitted That Met QC Criteria

July 12, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

NCCTG-N08C1
NCI-2009-01108 (Registry Identifier: CTRP (Clinical Trials Reporting System))
CDR0000631962 (Registry Identifier: PDQ (Physician Data Query))

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Study Overview

Status

Conditions

Intervention / Treatment

Detailed Description

Study Type

Enrollment (Actual)

Contacts and Locations

Study Locations

Participation Criteria

Eligibility Criteria

Ages Eligible for Study

Accepts Healthy Volunteers

Genders Eligible for Study

Sampling Method

Study Population

Description

Study Plan

How is the study designed?

Design Details

Number of groups / cohorts

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure

Time Frame

Secondary Outcome Measures

Outcome Measure

Time Frame

Collaborators and Investigators

Sponsor

Collaborators

Publications and helpful links

General Publications

Study record dates

Study Major Dates

Study Start

Primary Completion (Actual)

Study Completion (Actual)

Study Registration Dates

First Submitted

First Submitted That Met QC Criteria

First Posted (Estimate)

Study Record Updates

Last Update Posted (Estimate)

Last Update Submitted That Met QC Criteria

Last Verified

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Clinical Trials on Pain

Clinical Trials on pain questionnaires

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